Big Pharma and Section 337: The Next Frontier for Enforcement of Non-Orange Book Listed Pharmaceutical Drug Patents
- Daniel E. Yonan, Keeto Sabharwal, Mark Fox Evens, and Jeremiah Frueauf
- BNA's Pharmaceutical Law & Industry Report
With its recent vote to institute Investigation No. 337-TA-766, entitled Certain Gemcitabine and Products Containing Same, the United States International Trade Commission may have opened a new frontier for enforcing non-Orange Book listed patents. Investigations under Section 337 have traditionally been used by patent holders in the electrical and mechanical industries. However, as a result of the Commission’s decision, innovators may now begin using the Section 337 process to frustrate post-Orange Book patent certainty by adding additional barriers, significant risk and expense to generic drug entry into the US. This investigation represents a test case for an innovator to leverage the patents it has in its portfolio against generics that have approval to market a generic drug product, even after the Orange Book listed patents have either expired or been declared invalid.
For a more detailed look at this new avenue, see the attached PDF above.